Accuracy of the O2 MedTech PMS-3000 Monitor (NCT01418079) | Clinical Trial Compass
CompletedPhase 2
Accuracy of the O2 MedTech PMS-3000 Monitor
United States42 participantsStarted 2011-08
Plain-language summary
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Body Mass Index (BMI) of 18 to 30, inclusive
✓. No anticoagulant or platelet inhibitor use
✓. Oxygen saturation (SpO2) ≥ 95% on room air
✓. Able to tolerate breathing mask apparatus
Exclusion criteria
✕. Female with positive pregnancy test
✕. Beard or history of or anatomy suggestive of difficult airway
✕. Lab values outside normal range for the clinical site
✕. History of cigarette smoking or currently a cigarette smoker
✕. Current drug or alcohol abuse
✕. History of sleep apnea, high blood pressure (HBP), cardiac or pulmonary disease, gastroesophageal reflux, hemoglobinopathy, or coagulation abnormality
✕
What they're measuring
1
Accuracy of device to measure cerebral tissue oxygen saturation